Clinical relevance of single item quality of life indicators in cancer clinical trials

We investigated the hypothesis that global single-item quality-of-life indicators are less precise for specific treatment effects (discriminant validity) than multi-item scales but similarly efficient for overall treatment comparisons and changes over time (responsiveness) because they reflect the summation of the individual meaning and importance of various factors. Linear analogue self-assessment (LASA) indicators for physical well-being, mood and coping were compared with the Hospital Anxiety and Depression Scale (HAD), the Mood Adjective Check List (MACL) and the emotional behaviour and social interaction scales of the Sickness Impact Profile (SIP) in 84 patients with early breast cancer receiving adjuvant therapy. Discriminant validity was investigated by multitrait-multimethod correlation, responsiveness by standardized response mean (SRM). Discriminant validity of the indicators was present at baseline but less under treatment. Responsiveness was demonstrated by the expected pattern among treatments (P = 0.008). In patients without chemotherapy, the SRMs indicated moderate (0.5–0.8) to large (>0.8) improvements in physical well-being (0.70), coping (0.92), HAD anxiety (0.89) and depression (1.19), and MACL mental well-being (0.68). In patients with chemotherapy for the first 3 months, small but clinically significant improvements (>).2) included mood (0.38), coping (0.41), HAD axiety (0.31) and MACL mental well-being (0.35). Patients with 6 months chemotherapy showed no changes. The indicators also reflected mood disorders (HAD) and marked psychosocial dysfunction (SIP) at baseline and under treatment according to pre-defined cut-off levels. Global indicators were confirmed to be efficient for evaluating treatments overall and changes over time. The lower reliability of single as opposed to multi-item scales affects primarily their discriminant validity. This is less decisive in large sample sizes. © 2001 Cancer Research Campaign http://www.bjcancer.com

[1]  P. Butow,et al.  On the receiving end. IV: Validation of quality of life indicators. , 1991, Annals of oncology : official journal of the European Society for Medical Oncology.

[2]  R. Gelber,et al.  Quality of life assessment in patients receiving adjuvant therapy for breast cancer: the IBCSG approach. The International Breast Cancer Study Group. , 1997, Annals of Oncology.

[3]  G. Huston.  The Hospital Anxiety and Depression Scale. , 1987, The Journal of rheumatology.

[4]  J. Forbes,et al.  Impact of adjuvant therapy on quality of life in women with node-positive operable breast cancer , 1996, The Lancet.

[5]  R. Gelber,et al.  Quality of life assessment in patients receiving adjuvant therapy for breast cancer: The IBCSG approach , 1998 .

[6]  M. Bergner,et al.  The Sickness Impact Profile: Development and Final Revision of a Health Status Measure , 1981, Medical care.

[7]  M. Baum,et al.  EVALUATION OF QUALITY OF LIFE IN PATIENTS RECEIVING TREATMENT FOR ADVANCED BREAST CANCER , 1976, The Lancet.

[8]  M Baum,et al.  Psychological outcomes of different treatment policies in women with early breast cancer outside a clinical trial. , 1990, BMJ.

[9]  S. Sheather,et al.  Clinical applications of visual analogue scales: a critical review , 1988, Psychological Medicine.

[10]  H. Olsson,et al.  Anxiety and depression in breast cancer patients at start of adjuvant radiotherapy. Relations to age and type of surgery. , 1992, Acta oncologica.

[11]  M. Liang,et al.  Comparative Measurement Sensitivity of Short and Longer Health Status Instruments , 1992, Medical care.

[12]  P. Hersey,et al.  Prognostic value of quality of life scores in a trial of chemotherapy with or without interferon in patients with metastatic malignant melanoma. , 1993, European journal of cancer.

[13]  J. Brisson,et al.  Psychological distress after initial treatment for breast cancer: a comparison of partial and total mastectomy. , 1989, Journal of clinical epidemiology.

[14]  M. Liang,et al.  Comparisons of Five Health Status Instruments for Orthopedic Evaluation , 1990, Medical care.

[15]  N. Frasure-smith,et al.  Randomized trial of a psychologic distress screening program after breast cancer: effects on quality of life. , 1996, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[16]  R. Gelber,et al.  Quality of life measures for patients receiving adjuvant therapy for breast cancer: an international trial. The International Breast Cancer Study Group. , 1992, European journal of cancer.

[17]  A. Coates,et al.  On the receiving end--III. Measurement of quality of life during cancer chemotherapy. , 1990, Annals of oncology : official journal of the European Society for Medical Oncology.

[18]  C. Bouchard,et al.  Swedish obese subjects (SOS)--an intervention study of obesity. Baseline evaluation of health and psychosocial functioning in the first 1743 subjects examined. , 1993, International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity.

[19]  J. Brisson,et al.  Psychological distress after initial treatment of breast cancer. Assessment of potential risk factors , 1992, Cancer.

[20]  M. Sullivan,et al.  Measuring health in rheumatic disorders by means of a Swedish version of the sickness impact profile. Results from a population study. , 1986, Scandinavian journal of rheumatology.

[21]  D. Watson,et al.  Health complaints, stress, and distress: exploring the central role of negative affectivity. , 1989, Psychological review.

[22]  R C Aitken,et al.  Measurement of mood. , 1969, Proceedings of the Royal Society of Medicine.

[23]  L. Fallowfield,et al.  Are we using appropriate self-report questionnaires for detecting anxiety and depression in women with early breast cancer? , 1999, European journal of cancer.

[24]  C. Bengtsson,et al.  A comparison of overall health between patients with rheumatoid arthritis and a population with and without rheumatoid arthritis. , 1990, Scandinavian journal of rheumatology.

[25]  J. Ware.  SF-36 health survey: Manual and interpretation guide , 2003 .

[26]  D. Zerssen.  Clinical Self-Rating Scales (CSRS) of the Munich Psychiatric Information System (PSYCHIS München) , 1986 .

[27]  F. Cavalli,et al.  Defining clinical benefit in postmenopausal patients with breast cancer under second-line endocrine treatment: does quality of life matter? , 1999, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[28]  M. Watson,et al.  Relationships between emotional control, adjustment to cancer and depression and anxiety in breast cancer patients , 1991, Psychological Medicine.

[29]  Jacob Cohen.  Statistical Power Analysis for the Behavioral Sciences , 1969, The SAGE Encyclopedia of Research Design.

[30]  M. Perri,et al.  Single-Item Vs Multiple-Item Measures of Health-Related Quality of Life , 1991, Psychological reports.

[31]  Anastasia E. Raczek,et al.  The validity and relative precision of MOS short- and long-form health status scales and Dartmouth COOP charts. Results from the Medical Outcomes Study. , 1992, Medical care.

[32]  J F Forbes,et al.  Prognostic value of quality-of-life scores during chemotherapy for advanced breast cancer. Australian New Zealand Breast Cancer Trials Group. , 1992, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[33]  M. Tattersall,et al.  Improving the quality of life during chemotherapy for advanced breast cancer. A comparison of intermittent and continuous treatment strategies. , 1987, The New England journal of medicine.

[34]  F. Cavalli,et al.  Quality of life in postmenopausal patients with breast cancer after failure of tamoxifen: formestane versus megestrol acetate as second-line hormonal treatment. Swiss Group for Clinical Cancer Research (SAKK). , 1999, European journal of cancer.

[35]  R. Gelber,et al.  Responsiveness of a single-item indicator versus a multi-item scale: assessment of emotional well-being in an international adjuvant breast cancer trial. , 1996, Medical care.